NCT06909682 AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
| NCT ID | NCT06909682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Salerno |
| Condition | Chronic Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 205 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 205 participants in total. It began in 2025-08-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational, multicenter study is to evaluate whether AI-driven remote monitoring using a mini-invasive wearable device can improve clinical outcomes in adult patients (≥18 years) with chronic heart failure (CHF). The main questions it aims to answer are: * Can continuous remote monitoring reduce hospital admissions (emergency visits and hospitalizations) by 20% compared to standard care? * Does wearable-based remote monitoring improve functional, biochemical, and instrumental parameters in CHF patients? Researchers will compare patients using the wearable device (intervention group) to those receiving standard clinical follow-up (control group) to assess whether AI-driven monitoring leads to fewer hospitalizations, better disease management, and improved quality of life. Participants will: * Wear the EmbracePlus (Empatica Inc.) device continuously for six months (intervention group only). * Have their biometric data (SpO₂, HRV, EDA, respiratory rate, temperature, sleep quality) monitored remotely. * Receive automated alerts and teleconsultations if abnormal physiological changes are detected. * Attend scheduled follow-up visits (remote and in-person) for clinical evaluation and treatment adjustments. The study aims to provide real-world evidence on whether integrating wearable health technology with AI analytics can enhance CHF management and improve patient outcomes.
Eligibility Criteria
Inclusion Criteria * Age ≥ 18 years (adults of any sex) * Confirmed diagnosis of chronic heart failure (CHF) for at least 6 months prior to screening * Stable on optimized heart failure therapy for at least one month before enrollment * Any left ventricular ejection fraction (LVEF) classification, including: * Heart Failure with Reduced Ejection Fraction (HFrEF) * Heart Failure with Mid-Range Ejection Fraction (HFmrEF) * Heart Failure with Preserved Ejection Fraction (HFpEF) * NYHA Functional Class I, II, or III * History of at least one hospital admission or outpatient visit in the past 12 months requiring intravenous (IV) diuretics, vasodilators, or inotropes for CHF exacerbation * Ability to provide written informed consent or availability of a legally authorized representative Exclusion Criteria * NYHA Functional Class IV or anticipated heart transplant or ventricular assist device (VAD) implantation within 6 months of screening * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or dialysis dependence * Terminal comorbidities (e.g., advanced cancer, end-stage pulmonary disease) significantly limiting life expectancy * Pregnancy * Presence of skin conditions or allergies preventing prolonged use of a wearable device * Inability to comply with study procedures (e.g., cognitive impairment, significant psychiatric disorders)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06909682 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06909682 currently recruiting?
Yes, NCT06909682 is actively recruiting participants. Contact the research team at abramanti@unisa.it for enrollment information.
Where is the NCT06909682 trial being conducted?
This trial is being conducted at Salerno, Italy.
Who is sponsoring the NCT06909682 clinical trial?
NCT06909682 is sponsored by University of Salerno. The trial plans to enroll 205 participants.
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